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Not yet recruiting NCT07566442

Frenkel Exercises on Balance and Quality of Life Post Burns

No phase Interventional Burns Lower Limb Burn Injury

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: frenkel exercises, traditional physical therapy programme.
Who it may be relevant to
Registry conditions: Burns, Lower Limb Burn Injury. Basic parameters: 20 years — 45 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Effect of Frenkel Exercises on Balance and Quality of Life in Patients With Lower Limb Burns

Overview

Seventy patients of both sexes with thermal burn injuries, aged 25 to 45 years, will participate in this study. The participants will be randomly selected from the Outpatient Clinic of the Faculty of Physical Therapy. They will be randomly assigned into two equal groups, 35 patients each (study group and control group). Group A (Study Group): Patients in this group will receive Frenkel exercises in addition to a traditional physiotherapy program comprising stretching, strengthening exercises and scar management, 3 times a week for 8 weeks. While, Group B (Control Group): Patients in this group will receive traditional physiotherapy program, 3 times a week for 8 weeks.

Detailed description

Introduction: Severe burn injuries to the lower limbs result in reduced muscle strength, postural imbalance, limited walking ability, and diminished functional activities. This research aimed to study the impact of frenkel exercises on balance and quality of life, and determine the most effective treatment program for rehabilitation.

Material and methods: The primary outcome measures were balance, assessed using the Biodex Balance System, and quality of life, evaluated using a validated questionnaire. Secondary outcome measures included lower limb muscle strength, measured by a Lafayette Hand-Held Dynamometer (HHD), and functional ability, assessed using the Lower Extremity Functional Scale (LEFS). Seventy patients of both sexes with thermal burn injuries, aged 25 to 45 years, will participate in this study. The participants will be randomly selected from the Outpatient Clinic of the Faculty of Physical Therapy. They will be randomly assigned into two equal groups, 35 patients each (study group and control group). Group A (Study Group): Patients in this group will receive Frenkel exercises in addition to a traditional physiotherapy program comprising stretching, strengthening exercises and scar management, 3 times a week for 8 weeks. While, Group B (Control Group): Patients in this group will receive traditional physiotherapy program, 3 times a week for 8 weeks.

Interventions

  • Other frenkel exercises
    The program was conducted three times per week for eight weeks, with 30-minute sessions performed under visual guidance using slow, controlled, and repetitive movements to enhance coordination and balance. Exercises progressed from supine (hip, knee, and coordination tasks) to sitting (controlled leg movements and functional transitions), and then to standing activities focusing on static balance (weight shifting, narrow base, tandem stance). Finally, dynamic balance and gait training were intro
  • Other traditional physical therapy programme
    Participants received a supervised traditional physiotherapy program three times per week for eight weeks. Each 45-minute session included stretching exercises for the calf and hamstring muscles, followed by range of motion (ROM) and progressive strengthening exercises for the lower limbs using free weights. Training intensity progressed from 50%-60% of 3RM in the first week to 80%-85% by weeks 7-8, with three sets of ten repetitions per exercise. Scar management included 15-20 minutes of deep

Primary outcome measures

  • Berg Balance Scale (BBS) [Time frame: 8 weeks]
  • The Short Form 36 (SF-36) [Time frame: 8 week]
Secondary outcome measures (1)
  • Timed up and go test [Time frame: 8 weeks]

Eligibility criteria

Inclusion criteria

  • Body mass index (BMI) between 25-30 kg/m²
  • Total body surface area (TBSA) 30%-45% determined by rule of nines
  • Second-degree thermal burns affecting the lower limbs
  • After full wound healing
  • Ability to stand and walk independently or with minimal assistance
  • Ability to participate in balance training exercises

Exclusion criteria

  • Open wounds in or near the treatment area
  • Chemical or electrical burns or inhalation injuries
  • Musculoskeletal conditions affecting exercise or testing, or visual/hearing impairments
  • Uncontrolled cardiovascular or pulmonary diseases
  • Malignant conditions
  • Severe behavioral or cognitive disorders
  • Uncooperative patients
  • Proprioception deficit or balance impairment due to other diseases

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07566442 · 12519939987

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗